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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02821429
Other study ID # RC31/15/7850
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date January 2015
Est. completion date January 2019

Study information

Verified date June 2019
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Respiratory weaning failure worsens prognostic of patients following on-pump cardiac surgery. There are increasing evidences that pulmonary, diaphragmatic or cardiologic echographies are useful in order to improve this critical medical status.

Based both on a previous study conducted in the critical care unit of Purpan and on literature we hypothesize that a combined thoracic echography score could be of interest. We make the hypothesis that the use of a score based on thoracic combined echography (ETC = cardiac, pulmonary and diaphragmatic) allows to predict the failure of respiratory weaning in cardiac surgery and allows to improve the characterization of the causes of this failure


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2019
Est. primary completion date January 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult (> 18 years old) beneficiating of mechanical ventilation following cardiac surgery

- Weaning test period

- Patient insured under the French social security system

Exclusion Criteria:

- Tracheostomy

- Neurological disorders

- Need for prophylactic non invasive ventilation.

- Global obstructive lung disease with a forced expiratory volume < 50%.

- Judicial protection

- Patient already included in a trial still running.

- Pregnancy

Study Design


Intervention

Other:
Combined Thoracic Echography Record
This examination will be done to do the longitudinal follow-up of the patient

Locations

Country Name City State
France University Hospital Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of predictive value of combined Thoracic Echography (ETC) as assessed by difference in the ETC score before and after extubation 1 hour after the weaning test and 48h after
Secondary Evaluation of predictive value of combined Thoracic Echography (ETC) as assessed T tube Test score difference between patient who succeed or failed the weaning test H0 and 48h after the weaning test
Secondary Evaluation of diagnostic value of combined Thoracic Echography (ETC) after failure to weaning test as assessed be ECT scores collected H0, H1 and H48
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